Trial · NCT04792970
Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion
NCT04792970, Phase 4, Terminated, Duke University; results first posted 2023-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion. Trials, record NCT04792970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04792970
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Randomized Controlled Trial of Talc Instillation In Addition To Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients With Malignant Pleural Effusion
- NCT number
- NCT04792970
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 4 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Malignant Pleural Effusion
- Interventions
- Talc
- First posted
- 2021-03-11
- Last updated
- 2023-09-28
- Results first posted
- 2023-09-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Undergoing Accelerated Pleurodesis | Up to 90 Days | |
| Secondary | Dyspnea as Measured by Questionnaire | Baseline, 30 days, 90 Days | Borg Dyspnea Scale was used to rate difficulty of breathing. This scale starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. Lower scores on this scale equal a better outcome. |
| Secondary | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Baseline | Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) was evaluated for overall health status. The SF-36 is composed of eight multi-item scales (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health), with scores for each of these scales (or dimensions) ranging from 0 to 100. Higher scores indicate higher qualify of life. |
| Secondary | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | 30 days | Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) was evaluated for overall health status. The SF-36 is composed of eight multi-item scales (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health), with scores for each of these scales (or dimensions) ranging from 0 to 100. Higher scores indicate higher qualify of life. |
| Secondary | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days | 90 days | Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) was evaluated for overall health status. The SF-36 is composed of eight multi-item scales (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health), with scores for each of these scales (or dimensions) ranging from 0 to 100. Higher scores indicate higher qualify of life. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Undergoing Accelerated Pleurodesis | Up to 90 Days | Only participants who underwent pleurodesis while on study are included in the analysis | percentage of participants | NUMBER |
| SECONDARY | Dyspnea as Measured by Questionnaire | Baseline, 30 days, 90 Days | Data not collected on Standard Daily Drainage participant at day 90 due to pleurodesis at the day 30 follow-up visit. | score on a scale | NUMBER |
| SECONDARY | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Baseline | score on a scale | NUMBER | |
| SECONDARY | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 30 Days | 30 days | score on a scale | NUMBER | |
| SECONDARY | Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at 90 Days | 90 days | Data not collected on Standard Daily Drainage participant at day 90 due to pleurodesis at the day 30 follow-up visit. | score on a scale | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Undergoing Accelerated Pleurodesis | Standard Daily Drainage | 100 | percentage of participants | ||
| Dyspnea as Measured by Questionnaire | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Baseline | 2 | score on a scale | |
| Dyspnea as Measured by Questionnaire | Standard Daily Drainage | Baseline | 0.5 | score on a scale | |
| Dyspnea as Measured by Questionnaire | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Day 30 | 2 | score on a scale | |
| Dyspnea as Measured by Questionnaire | Standard Daily Drainage | Day 30 | 1 | score on a scale | |
| Dyspnea as Measured by Questionnaire | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Day 90 | 0 | score on a scale | |
| Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Physical functioning | 30 | score on a scale | |
| Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Standard Daily Drainage | Physical functioning | 25 | score on a scale | |
| Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | Role limitations due to physical health | 0 | score on a scale | |
| Qualify of Life as Measured by Short Form 36 Health Survey (SF-36) at Baseline | Standard Daily Drainage | Role limitations due to physical health | 0 | score on a scale |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 2 | |
| Overall Study | STARTED | Standard Daily Drainage | 2 | |
| Overall Study | COMPLETED | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 1 | |
| Overall Study | COMPLETED | Standard Daily Drainage | 1 | |
| Overall Study | NOT COMPLETED | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 1 | |
| Overall Study | NOT COMPLETED | Standard Daily Drainage | 1 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Catheter Occlusion | Respiratory, thoracic and mediastinal disorders | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 0 | 2 | 0 |
| other | Catheter Occlusion | Respiratory, thoracic and mediastinal disorders | Standard Daily Drainage | 1 | 2 | 1 |
| other | Worsening Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 0 | 2 | 0 |
| other | Worsening Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Standard Daily Drainage | 1 | 2 | 1 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 1 | 2 | 1 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Standard Daily Drainage | 0 | 2 | 0 |
| serious | Suspected Pleural Catheter Infection | Respiratory, thoracic and mediastinal disorders | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 0 | 2 | 0 |
| serious | Suspected Pleural Catheter Infection | Respiratory, thoracic and mediastinal disorders | Standard Daily Drainage | 1 | 2 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 1 | 2 |
| Total, all-cause mortality | Standard Daily Drainage | 0 | 2 |
| Total, other adverse events | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 0 | 2 |
| Total, other adverse events | Standard Daily Drainage | 2 | 2 |
| Total, serious adverse events | Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage | 1 | 2 |
| Total, serious adverse events | Standard Daily Drainage | 1 | 2 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage vs Standard Daily Drainage: deaths from any cause | Trial comparisons |
| Talc Instilled Via Tunneled Pleural Catheter Combined With Standard Daily Drainage vs Standard Daily Drainage: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04792970
GET https://conductscience.org/api/trials/v1/NCT04792970/results?page=2